Protection of Autonomic Nervous System During Lower Spine Surgical Procedures: A Safety and Feasibility Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 主要终点
- Amplitude and frequency of changes in free-run smooth muscle EMG under varying surgical and anesthetic conditions.
研究概览
简要总结
A safety and feasibility study of free-run and stimulated corporal electromyography (EMG) to assess autonomic neural function during spinal and/or pelvic surgery in women and men.
详细描述
This is a safety and efficacy trial to assess autonomic neural function monitoring during spinal and/or pelvic surgery.
During standard intraoperative neuromonitoring, additional smooth muscle free-running and stimulated EMG will be recorded from corporal tissues (corpus spongiosum) of male and female genitalia from individual patients. Throughout the duration of the spinal surgery, the neurophysiologist will continuously monitor autonomic function. Smooth muscle free-running (continuous) and stimulated EMG will be recorded.
EMG data and additional demographics and clinical data (e.g. operative time, adverse events) will be collected for each patient. The success rates of 1) credible and safe EMG recording and 2) positive EMG responses to each stimulation method will be calculated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be ≥ 18 years of age
- •Patients are undergoing lumbar spine surgical and/or pelvic procedure at Abbott Northwestern Hospital
- •Patients must be capable of understanding the informed consent and have signed the informed consent document prior to any study-specific screening procedures or evaluations being performed.
排除标准
- •Patients ≥ 70 years of age
- •Patients with obvious groin infection and/or herniation
- •Patients with ongoing psychiatric concerns
结局指标
主要结局
Amplitude and frequency of changes in free-run smooth muscle EMG under varying surgical and anesthetic conditions.
时间窗: Duration of surgery
Free-run smooth muscle EMG will be monitored continuously throughout the duration of surgery. Any changes in the EMG, as indicated by fluctuations in amplitude and/or frequency, will be recorded.
次要结局
- Amplitude and frequency of changes in smooth muscle EMG resulting from the inadvertent effect of intraoperative monitoring stimulations and recordings.(Duration of Surgery)
- The believable and repeatable smooth muscle EMG response, if any, measured by amplitude and frequency after deliberate spinal/extra-spinal neural stimulations.(Duration of surgery)
研究者
Stanley Skinner
Neurophysiologist
Allina Health System